Cleared Traditional

K243569 - TriMed Wrist Fixation System (Volar Bearing Plates) (FDA 510(k) Clearance)

Also includes:
TriMed Wrist Fixation System (Volar Fixed Angle Plates) TriMed Wrist Fixation System (Hook Plates) TriMed Wrist Fixation System (Pin Plates) TriMed Wrist Fixation System (Peg Plates) TriMed Wrist Fixation System (Shear Plates) TriMed Wrist Fixation System (Wireform plates and Washer) TriMed Wrist Fixation System (Wireforms) TriMed Wrist Fixation System (Torx Cortical Screws) TriMed Wrist Fixation System (Torx Threaded Pegs)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243569 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
58d
Days
Class 2
Risk

K243569 is an FDA 510(k) clearance for the TriMed Wrist Fixation System (Volar Bearing Plates). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on January 15, 2025 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all TriMed, Inc. devices

Submission Details

510(k) Number K243569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2024
Decision Date January 15, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1306
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